This is a summary of the European public assessment report (EPAR) for Replagal. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Replagal.
Replagal : EPAR - Summary for the public (PDF/82.69 KB)
First published: 12/04/2007
Last updated: 29/07/2015
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Shire Human Genetic Therapies AB
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21/11/2017 Replagal - EMEA/H/C/000369 - IAIN/0096
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Other alimentary tract and metabolism products
Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).